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NCT Number: NCT04172220

Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state.

This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Aviano, PN, 33081, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First diagnosis of histologically confirmed breast cancer
  • Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy)
  • Able to provide adequate informed consent
  • With intact cognitive abilities

Exclusion criteria

  • Ongoing pregnancy
  • In therapy or in follow-up for other cancers at the time of the study
  • Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases
  • History of documented allergy or previous adverse reaction to local anesthetics
  • Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management
  • Unable to comply to study protocol schedule for logistic or other reasons
  • Refusal to participate to the study (absence of signed informed consent)

Treatment and study plan

midazolam

Drug

1-2 mg of Midazolam as premedication.

PECS

Procedure

Loco-regional anesthesia: PEC I and serratus plane block with an echoguided technique.

For the PEC I: infiltration of 10 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of the pectoralis major muscle and the small pectoralis muscle at the height of the third rib on the anterior axillary line.

For the serratus plane block: identification of the fifth rib on the average axillary line and infusion of about 20 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of large dorsal muscle and of the anterior serratus muscle.

Opioid-free general anesthesia

Procedure

Induction with Propofol 1.5-2 mg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in Target-Controlled Infusion (TCI) of 6 mcg/ml, subsequently modified to maintain a Bispectral Index (BIS) value between 40 and 60.

Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.

In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.

General Anesthesia

Procedure

Induction with Propofol 1.5-2 mg/kg; Fentanyl 1μg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in TCI of 6 mcg/ml, subsequently modified to maintain a BIS value between 40 and 60.

Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.

In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.

Postoperative analgesia

Procedure

Paracetamol 1000 mg every 8 hours for the first 24 hours, Ketorolac 30 mg in case of pain control failure (Numeric Rating Scale- NRS>4) which can be administered every 8 hours at most (max 90 mg / 24 hours), Morphine 10-20 mg IV in 24 hours as rescue analgesia.

Primary outcomes

  1. 24h NLR variation

    Time frame: Pre-operative and at 24 hours after the end of surgery

    Intra-patient variation of the NLR value between the pre-operative and the first post-operative day

Secondary outcomes

  1. 1h NLR variation

    Time frame: Pre-operative, 1 hour and 24 hours after the end of surgery

    Intra-patient variation of the NLR value between pre-operative and 1 hour after the end of surgery, and between 1 hour after the end of surgery and 24 hours after the end of surgery

  2. Opioid consumption

    Time frame: 24 hours

    Consumption of intra-operative Fentanyl and post-operative Morphine hydrochloride during the first 24 hours after surgery

  3. Complication

    Time frame: until hospital discharge, an average of 48 hours

    Complications related to the loco-regional anesthesia technique or to the administration of the local anesthetic. For pain evaluation, the validated Numeric Rating Scale (NRS) will be used, the score ranges from 0 to 10 with higher values corresponding to worse pain.

  4. Chronic pain

    Time frame: 3, 6 and 12 months after surgery

    Chronic pain after surgery will be assessed with Brief Pain Inventory questionnaire (composed by pain severity and pain interference scores). "Douleur Neuropathique 4" (DN4) questionnaire will be used for the identification of neuropathic pain. All the scores range from 0 to 10, with 10 indicating the worst results.

  5. Change in the levels of circulating cytokines in the post-operative period (one hour and 24 hours after surgery), compared to the baseline pre-operative values, in the two arms

    Time frame: 24 hours

    differences in fold change of selected cytokines between the two arms

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study title

Variation of the Neutrophil To Lymphocyte Ratio During Opioid-Free General Anesthesia Associated With Thoracic Wall Blocks Vs General Anesthesia, in Breast Cancer Quadrantectomy: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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